FDA Nod For LLY/INCY RA Drug, JAZZ Hits Right Tones, SLS' Study Stopped Early

(RTTNews) - Today's Daily Dose brings you news about updated results from Celgene's TRANSCEND study; Epizyme's mesothelioma trial results; FDA approval of lower dose of OLUMIANT; Jazz Pharma's phase III TONES 5 study results, and early termination of Sellas' Phase 2b NeuVax study in combination with Herceptin in HER2 1+/2+ breast cancer patients.

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Celgene Corp. (CELG) has announced that its updated six-month safety and efficacy data from a phase I study of lisocabtagene maraleucel (liso-cel) in patients with relapsed/refractory (r/r) aggressive B-cell non-Hodgkin lymphoma continue to support a potential best-in-class CD19 CAR T profile.

In the study, dubbed TRANSCEND, at six months, 49% of patients remained in remission, with 46% maintaining a complete response (CR). When durability of response beyond six months was evaluated across all dosing levels, 93% of patients in CR remained in CR at data cut off.

CELG closed Friday's trading at $79.04, up 0.46%.

Epizyme Inc.'s (EPZM) phase II study of its lead candidate Tazemetostat in relapsed/refractory malignant mesothelioma patients with BRCA1-associated protein 1 (BAP1) loss-of-function has met the primary endpoint.

According to the study results, 51 percent of patients achieved disease control at 12 weeks, which is more than the pre-specified disease control rate (DCR) threshold of greater than or equal to 35%.

DCR is defined as complete response, partial response (PR) or stable disease.

EPZM closed Friday's trading at $17.20, down 1.43%.

The FDA, on Friday, approved OLUMIANT of 2-mg dosage for the treatment of patients with moderate-to-severe rheumatoid arthritis.

OLUMIANT (Baricitinib), a once-daily oral JAK inhibitor, is co-developed by Eli Lilly and Co. (LLY) and Incyte Corp. (INCY). The companies had sought FDA approval for two doses of OLUMIANT - i.e., 2mg and 4mg.

The FDA's decision to approve only the 2-mg dosage of OLUMIANT is in line with the advisory panel's recommendation in April of this year, to approve the lower dose of the drug.

In April 2017, the FDA had turned down Baricitinib, asking the companies to submit additional clinical data on the drug's dosing and safety profile.

OLUMIANT sports a Boxed Warning for the risk of serious infections, malignancies and thrombosis.

The drug will be launched by Lilly in the U.S. by the end of the second quarter of 2018. The Company said it will offer OLUMIANT at a price 60% less than the leading TNF inhibitor.

Incyte is now eligible to receive a $100 million milestone payment from Lilly as a result of the OLUMIANT approval, which Incyte expects to recognize in the second quarter of 2018.

INCY closed Friday's trading at $67.91, down 0.53%.

Jazz Pharmaceuticals plc's (JAZZ) phase III TONES 5 study of investigational treatment Solriamfetol has demonstrated long-term maintenance of efficacy and a tolerable safety profile of the compound in patients with excessive sleepiness due to narcolepsy or obstructive sleep apnea.

The study met the primary endpoint of a significant change in Epworth Sleepiness Scale and secondary endpoints of Patient underscore potential for best-in-class CAR T profile for patients with poor prognosis and Clinician Global Impression of Change.

The New Drug Application for Solriamfetol is under FDA review, with a decision expected on December 20, 2018.

JAZZ closed Friday's trading at $170.75, up 1.04%.

SELLAS Life Sciences Group Inc. (SLS) has decided to terminate early the Phase 2b independent investigator-sponsored clinical trial of NeuVax in combination with Herceptin in HER2 1+/2+ breast cancer patients, thanks to the trial meeting key clinical objectives.

The decision to early terminate the phase 2b study was based in part on the previously announced recommendation of the independent Data Safety Monitoring Board to further advance the development of the NeuVax + Herceptin combination for the triple negative breast cancer (TNBC) patient population.

SLLS closed Friday's trading at $5.53, up 6.55%.